The vagina normally contains a number of microorganisms. Vaginal infections may occur as a result of the presence of certain quantities and/or types of bacteria, fungus (yeast) or parasite. Parasites such as trichomonas vaginalis are transmitted sexually whereas bacterial and yeast infections may occur even without sexual activity. Effective treatment depends on accurately determining the type of vaginal infection.
Bacterial vaginosis (“BV”) is a disease of the vagina that occurs when the normal bacterial flora are disturbed. BV can be diagnosed by the presence of at least three of the following criteria, known as the Asmel criteria:                1. homogeneous discharge (colour and amount may vary);        2. the presence of clue cells (greater than 20%) under a microscope;        3. a vaginal pH of greater than 4.5; and        4. the release of a fishy odor on adding potassium hydroxide (“KOH”) solution.        
In trichomonas vaginalis (a parasitic infection) the vaginal fluid has the appearance of frothy, yellow-green vaginal discharge with a strong odor before the KOH test.
In a fungal, such as yeast infection, the vaginal fluid has the typical appearance of a whitish, thick appearance and texture, like cottage cheese and is odourless before and after the KOH test.
Vaginal infections are common and many women seek treatment of vaginal infections with over the counter remedies. Due to the common nature of these infections and the fact that many women seek their own remedies, there is a need for infected women, doctors and nurses to be able to collect a vaginal fluid sample and to easily identify potential bacterial or fungal infections. There is a need for a testing device which would allow the consumer or professionals to collect, examine, and then apply the sample to tests for pH, bacterially derived amines (“BDA”) released with KOH solution, and other tests to diagnose potential infections. Such a testing device would be helpful in directing a woman to seek help from a physician and/or treat appropriately. One or more diagnostic tests, contained in a simple, easy-to-use, self-contained device could help to successfully treat BV and yeast infections and reduce the risk of subsequent associated problems (such as, pre-term labour, pelvic inflammatory disease (“PID”), increased risk of contracting sexually transmitted diseases such as HIV, etc.).
There are a number of ways in which fluid samples can be collected from the body and tested, including the use of a swab to collect a fluid sample and then application of the sample on the swab to a further device or location in order to test the sample for infectious agents or other indicia which aid in diagnosis of a disease or abnormality. More specifically and by way of example, there are numerous devices for collecting and testing vaginal fluid.
There is, currently, no all in one test available over the counter that permits collection of a sample of vaginal fluid, visual examination of its appearance for colour, consistency, and viscosity, and application of the sample to tests which would help distinguish pH, the presence of BDA's, and other tests to enable an accurate and/or differential diagnosis of fungal and bacterial infections. Proper diagnosis of vaginal infections reduces inappropriate treatments and the subsequent infections that arise from poor and/or improper treatment.
U.S. Pat. No. 5,738,634 discloses a stick device with a pH detector at one end for detecting the pH of vaginal moisture and a color measurement means. U.S. Pat. No. 5,425,377 includes a pH colorimetric measurement strip on the stick with the pH detector means.
U.S. Pat. No. 6,083,178 likewise discloses a stick device with a pH detector at one end (sized for application to a zone adjacent the wall of the vagina) for detecting the pH of vaginal moisture and additionally may include a protective layer over the pH detector whereby the vaginal moisture will penetrate the layer, but the pH detector will not come in contact with vaginal tissue. U.S. Pat. No. 6,283,927 also has a probe with pH detection means, whereby the probe is flat on at least one side. U.S. Pat. No. 6,496,441 additionally requires an edge presented generally longitudinally for limiting probe insertion into the vagina. All of these devices only detect pH and are thus not sufficient to make an accurate diagnosis of bacterial or fungal infection.
U.S. Pat. No. 5,998,161 discloses a method of detecting pathogenic bacteria wherein a moisture receiver is combined with a reactant(s) to produce a colour change upon contact with an amine, and a change in colour indicates the presence of pathogenic bacteria.
U.S. Pat. No. 6,013,036 includes a carrier with detecting means for detecting two conditions, the second of which is indicated as being for detection of pathogenic bacteria, by a “flowable fluid reactant container configured to allow controlled release of reactant fluid to react with bacteria containing vaginal or urethral moisture”.
U.S. Patent Application Publication No. 2007/0073192 describes an apparatus and method, whereby a probe is inserted in the vagina and is manipulable to transfer vaginal moisture to a pH test and to a hydroxide carrier such that amines are detected.
None of the devices or methods set out in the prior art and devices currently available collect a body fluid sample and test it all within the device itself. Accordingly, there is a need for such an all in one sample collection and testing device and method of use.